| 2026-03-12 |
Class I
|
Ongoing |
Z-1797-2026 |
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 |
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Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of be… |
| 2025-09-11 |
Class II
|
Ongoing |
Z-0132-2026 |
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify… |
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The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying f… |
| 2025-05-23 |
Class II
|
Ongoing |
Z-2016-2025 |
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version… |
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Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot… |
| 2023-11-30 |
Class I
|
Ongoing |
Z-0591-2024 |
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap… |
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The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insuli… |
| 2023-02-28 |
Class II
|
Ongoing |
Z-2618-2023 |
Omnipod 5 Automated Insulin Delivery System |
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An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated… |
| 2022-11-14 |
Class II
|
Ongoing |
Z-0423-2023 |
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-00… |
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The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring… |
| 2022-10-17 |
Class I
|
Terminated |
Z-0154-2023 |
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Ass… |
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The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire haza… |
| 2021-02-01 |
Class II
|
Terminated |
Z-1203-2021 |
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318… |
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Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipo… |
| 2020-04-02 |
Class II
|
Terminated |
Z-2165-2020 |
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage… |
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After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the co… |
| 2020-04-02 |
Class II
|
Terminated |
Z-2164-2020 |
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: … |
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After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the co… |
| 2020-02-13 |
Class II
|
Terminated |
Z-1553-2020 |
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - … |
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In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user… |